Methods and devices for improving mitral valve function

ABSTRACT

The various aspects of the invention pertain to devices and related methods for treating heart conditions, including, for example, dilatation, valve incompetencies, including mitral valve leakage, and other similar heart failure conditions. The devices and related methods of the present invention operate to assist in the apposition of heart valve leaflets to improve valve function. According to one aspect of the invention, a method improves the function of a valve of a heart by placing an elongate member transverse a heart chamber so that each end of the elongate member extends through a wall of the heart, and placing first and second anchoring members external the chamber. The first and second anchoring members are attached to first and second ends of the elongate member to fix the elongate member in a position across the chamber so as to reposition papillary muscles within the chamber.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to devices and related methods forimproving the function of heart valves, and more particularly to devicesand related methods that passively assist in the apposition of heartvalve leaflets to improve valve function of poorly functioning valves.

[0003] 2. Description of the Related Art

[0004] Heart failure is a condition whereby the left ventricle becomesenlarged and dilated as a result of numerous etiologies. Initial causesof heart failure include chronic hypertension, myocardial infarction,mitral valve incompetency, and other dilated cardiomyopathies. With eachof these conditions, the heart is forced to overexert itself in order toprovide the cardiac output demanded from the body during its variousdemand states. The result is an enlarged left ventricle.

[0005] A dilated heart, and particularly a dilated left ventricle, cansignificantly increase the tension and/or stress in the heart wall bothduring diastolic filling and systolic contraction, which contributes toongoing dilatation of the chamber. Prior treatments for heart failureinclude pharmacological treatments, assist devices such as pumps, andsurgical treatments such as heart transplant, dynamic cardiomyoplasty,and the Batista partial left ventriculectomy. These prior treatments aredescribed briefly in U.S. Pat. No. 5,961,440 to Schweich, Jr. et al.,issued Oct. 5, 1999 and entitled “Heart Wall Tension Reduction Apparatusand Method,” the complete disclosure of which is incorporated byreference herein.

[0006] A more recent concept for treating heart failure applies one ormore splints onto the heart, and particulary the left ventricle, toreduce the myocardial muscular stresses encountered during pumping. Manyexamples of such approaches are disclosed in the incorporated U.S. Pat.No. 5,961,440. One example includes one or more transventricular splintsplaced across the left ventricle. Each splint may include a tensionmember extending across the ventricle and anchors disposed on oppositeends of the tension member and placed on the external surface of theheart.

[0007] Mitral valve incompetency or mitral valve regurgitation is acommon comorbidity of, congestive heart failure. As the dilation of theventricle proceeds, valve function may worsen. The resultant volumeoverload condition, in turn, increases ventricular wall stress therebyadvancing the dilation process, which may further worsen valvedysfunction.

[0008] In heart failure, the size of the valve annulus (particularly themitral valve annulus) increases while the area of the leaflets of thevalve remains constant. This may lead to an area of less coaptation ofthe valve leaflets, and, as a result, eventually to valve leakage.Moreover, in normal hearts, the annular size contracts during systole,aiding in valve coaptation. In heart failure, there is poor ventricularfunction and elevated wall stress. These effects tend to reduce annularcontraction and distort annular size, often exacerbating mitral valveregurgitation. In addition, as the chamber dilates, the papillarymuscles (to which the leaflets are connected via the chordae tendonae)may move radially outward and downward relative to the valve, andrelative to their normal positions. During this movement of thepapillary muscles, however, the various chordae lengths remainsubstantially constant, which limits the full closure ability of theleaflets by exerting tension prematurely on the leaflets. This conditionis commonly referred to as “chordal tethering.” The combination ofannular changes and papillary changes results in a poorly functioningvalve.

[0009] It has been observed that for at least certain placements, ororientations, of the one or more transventricular splints in humans, apre-existing mitral valve incompetency can be exacerbated by thepresence and impact of the tightened splints. The splints and the localdeformation they impart may further alter the positions of the papillarymuscles in such a way that the chordae do not allow as complete of aclosure of the mitral valve, or that rotation of portions of theventricular wall (to which additional chordae may be attached) may“tighten” one valve leaflet and “loosen” the other. In this manner, theleaflets may not close at the same level relative to the annulus,causing increased retrograde leakage through the valve.

[0010] Even in instances where the placement of splints does notcontribute to further mitral valve leakage, it may be desirable toprovide a therapy which could also correct the valve incompetency. Aheart with even a small amount of regurgitation may benefit from notonly the stress reducing functions of the ventricular splints asdescribed above, but also from the elimination of the regurgitation,which will further off-load the pumping requirements of the myocardium.

[0011] While currently available methods of mitral valve repair orreplacement are possible to employ in conjunction with ventricularsplinting, they typically require opening the heart to gain directaccess to the valve and its annulus. This type of access necessitatesthe use of cardiopulmonary bypass, which can introduce additionalcomplications to the surgical procedure. Since the implantation of thesplints themselves do not require the patient to be on cardiopulmonarybypass, it would be advantageous to devise a technique which couldimprove the mitral valve without the need for cardiopulmonary bypass.The ability to improve the mitral valve function without the need forcardiopulmonary bypass would be an, advantage, both in conjunction withventricular splinting, and also as a stand-alone therapy.

SUMMARY OF THE INVENTION

[0012] Objects and advantages of the invention will be set forth in partin the description which follows, and in part will be obvious from thedescription, or may be learned by practice of the invention. The objectsand advantages of the invention will be realized and attained by meansof the elements and combinations particularly pointed out in theappended claims. To achieve the objects and in accordance with thepurpose of the invention, as embodied and broadly described herein, oneaspect of the invention comprises a method for improving the function ofa valve of a heart. The method includes the steps of placing an elongatemember transverse a heart chamber so that each end of the elongatemember extends through a wall of the heart, and placing first and secondanchoring members external to the chamber. The first and secondanchoring members are attached to first and second ends of the elongatemember to fix the elongate member in a position across the chamber so asto reposition papillary muscles within the chamber.

[0013] According to another aspect, the invention comprises a method forimproving the function of a valve of a heart. The method includes thesteps of placing an elongate member transverse a heart chamber so that afirst end of the elongate member extends through a wall of the heartbetween two papillary muscles, and a second end of the elongate memberextends through a septum of the heart; placing a first anchoring memberexternal the heart; and placing a second anchoring member inside theheart adjacent the septum. The first and second anchoring members areattached to the first and second ends of the elongate memberrespectively to fix the elongate member in a position across the heartchamber.

[0014] According to a further aspect, the invention comprises a methodfor improving the function of a valve of a heart. The method includesthe steps of placing an elongate member transverse a heart chamber sothat each end of the elongate member extends through a wall of theheart; and placing first and second anchoring members external thechamber. The first and second anchoring members are attached to the endsof the elongate member to fix the elongate member in a position acrossthe chamber. The position is superior to the papillary muscles andproximate and substantially across the valve.

[0015] According to an even further aspect, the invention comprises asplint for improving the function of a valve of a heart. The splintincludes an elongate member configured to be positioned transverse aheart chamber so that each end of the elongate member extends through awall of the heart, and first and second anchoring members configured tobe positioned external the chamber and attached to the ends of theelongate member to fix the elongate member in a position across thechamber. The first anchoring member includes a first portion configuredto contact a first region of the heart proximate the valve to change ashape of the valve. Preferably, the first portion will contact a firstregion of the heart proximate the valve annulus to change the shape ofthe valve annulus.

[0016] According to another aspect, the invention comprises a splint forimproving the function of a valve of a heart. The splint includes anelongate member configured to be positioned transverse a heart chamberso that each end of the elongate member extends through a wall of theheart, first and second anchoring members configured to be positionedexternal the chamber and attached to the ends of the elongate member tofix the elongate member in a position across the chamber, a thirdanchoring member connected to at least one of the first and secondanchoring members by a connection member. The third anchoring member isconfigured to contact a region of the heart proximate the valve tochange a shape of the valve.

[0017] According to a further aspect, the invention comprises a devicefor improving the function of a valve of a heart. The device includes afirst splint having a first elongate member configured to be positionedtransverse a heart chamber so that each end of the elongate memberextends through a wall of the heart, and a first anchoring memberconfigured to be positioned external the chamber and attached to a firstend of the first elongate member. The device further includes a secondsplint having a second elongate member configured to be positionedtransverse a heart chamber so that each end of the second elongatemember extends through a wall of the heart, and a second anchoringmember configured to be positioned external the chamber and attached toa first end of the second elongate member. The device also includes aconnecting mechanism configured to be connected to the second ends ofeach of the first and second elongate members external the chamber andpress the wall of the heart chamber to change a shape of the valve.

[0018] Yet a further aspect of the invention includes a method forimproving cardiac function, comprising placing a first member relativeto a heart chamber to alter the cross-sectional shape of the chamber andplacing a second member relative to a valve of the heart chamber toassist in apposition of leaflets of the valve.

[0019] According to an even further aspect, the invention includes amethod of improving the function of a valve of a heart comprisingapplying a force to an exterior surface of a wall surrounding a chamberof the heart substantially at a location of the valve to alter a shapeof the valve.

[0020] Yet a further aspect of the invention includes a method forimproving the function of a valve of a heart comprising placing a devicerelative to the heart to alter a shape of the valve and adjusting thedevice relative to the heart based on data obtained during the adjustingfrom real-time monitoring of valve function.

[0021] It is to be understood that both the foregoing generaldescription and the following detailed description are exemplary andexplanatory only and are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The accompanying drawings, which are incorporated in andconstitute a part of this specification, illustrate several embodimentsof the invention and together with the description, serve to explain theprinciples of the invention.

[0023]FIG. 1 is a transverse cross section of the left and rightventricles of a human heart showing the placement of splints accordingto an orientation for lessening myocardial muscular stresses;

[0024]FIG. 2a is a transverse cross section of the left and rightventricles of a human heart showing the orientation of splints accordingto an embodiment of the present invention for lessening myocardialmuscular stresses and assisting in apposition of valve leaflets;

[0025]FIG. 2b is a vertical cross section of the left and rightventricles of a human heart showing another orientation of ventricularshape change splints according to an embodiment of the present inventionfor lessening myocardial muscular stresses and assisting in appositionof valve leaflets;

[0026]FIG. 3a is a transverse cross section of the left and rightventricles of a human heart showing an orientation of a mitral valvesplint used in combination with a series of transventricular splintsaccording to an embodiment of the present invention for lesseningmyocardial muscular stresses and assisting in apposition of valveleaflets;

[0027]FIG. 3b is an external view of a human heart showing theorientation of the mitral valve splint and series of transventricularsplints of FIG. 3a;

[0028]FIG. 3c is a transverse cross section of the left and rightventricle of a human heart showing a various orientations for a mitralvalve splint used in combination with a series of transventricularsplints according to an embodiment of the present invention;

[0029]FIG. 4a is an external view of a human heart showing a series oftransventricular splints, with the superior-most splint having an anchorstructure according to an embodiment of the present invention thatassists in apposition of valve leaflets;

[0030]FIG. 4b is an external view of a human heart showing a series oftransventricular splints, with the superior most splint having an anchorstructure and a connection mechanism between the superior most andmiddle anchors according to yet another embodiment of the presentinvention that assists in apposition of valve leaflets;

[0031]FIG. 4c is a perspective view of an anchor assembly for atransventricular splint according to yet another embodiment of thepresent invention that assists in apposition of valve leaflets andrepositioning of papillary muscles;

[0032]FIG. 5a is a transverse cross section of the left and rightventricles of a human heart showing the placement of splints accordingto an orientation for lessening myocardial muscular stresses with anaccessory anchor assembly according to an embodiment of the presentinvention to assist in apposition of valve leaflets;

[0033]FIG. 5b is a transverse cross section of the left and rightventricles of a human heart showing the placement of splints accordingto an orientation for lessening myocardial muscular stresses with anaccessory anchor assembly according to another embodiment of the presentinvention to assist in apposition of valve leaflets;

[0034]FIG. 6 is a transverse cross section of the left and rightventricles of a human heart showing an orientation of a mitral valvesplint used in combination with a series of transventricular splints,with an interconnecting mechanism according to an embodiment of thepresent invention for lessening myocardial muscular stresses andassisting in apposition of valve leaflets; and

[0035]FIG. 7 is a perspective view of a heart with an external splintdevice and mitral valve anchor assembly and connecting mechanismdisposed relative to the left ventricle to alter the shape of the leftventricle and to assist in apposition of valve leaflets according to anembodiment of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] The various aspects of the invention to be discussed hereingenerally pertain to devices and methods for treating heart conditions,including, for example, dilatation, valve incompetencies, includingmitral valve leakage, and other similar heart failure conditions. Eachdevice of the present invention preferably operates passively in that,once placed in the heart, it does not require an active stimulus, eithermechanical, electrical, or otherwise, to function. Implanting one ormore of the devices of the present invention operates to assist in theapposition of heart valve leaflets to improve valve function. Inaddition, these devices may either be placed in conjunction with otherdevices that, or may themselves function to alter the shape or geometryof the heart, locally and/or globally, and thereby further increase theheart's efficiency. That is, the heart experiences an increased pumpingefficiency through an alteration in its shape or geometry andconcomitant reduction in stress on the heart walls, and through animprovement in valve function.

[0037] The inventive devices and related methods offer numerousadvantages over the existing treatments for various heart conditions,including valve incompetencies. The devices are relatively easy tomanufacture and use, and the surgical techniques and tools forimplanting the devices of the present invention do not require theinvasive procedures of current surgical techniques. For instance, thesurgical technique does not require removing portions of the hearttissue, nor does it necessarily require opening the heart chamber orstopping the heart during operation. For these reasons, the surgicaltechniques for implanting the devices of the present invention also areless risky to the patient than other techniques. The less invasivenature of the surgical techniques and tools of the present invention mayalso allow for earlier intervention in patients with heart failureand/or valve incompetencies.

[0038] The disclosed inventive devices and related methods involvegeometric reshaping of the heart and treating valve incompetencies. Incertain aspects of the inventive devices and related methods,substantially the entire chamber geometry is altered to return the heartto a more normal state of stress. Models of this geometric reshaping,which includes a reduction in radius of curvature of the chamber walls,can be found in U.S. Pat. No. 5,961,440 incorporated above. Prior toreshaping the chamber geometry, the heart walls experience high stressdue to a combination of both the relatively large increased diameter ofthe chamber and the thinning of the chamber wall. Filling pressures andsystolic pressures are typically high as well, further increasing wallstress. Geometric reshaping according to the present invention reducesthe stress in the walls of the heart chamber to increase the heart'spumping efficiency, as well as to stop further dilatation of the heart.

[0039] Although many of the methods and devices are discussed below inconnection with their use in the left ventricle and for the mitral valveof the heart, these methods and devices may be used in other chambersand for other valves of the heart for similar purposes. One of ordinaryskill in the art would understand that the use of the devices andmethods described herein also could be employed in other chambers andfor other valves of the heart. The left ventricle and the mitral valvehave been selected for illustrative purposes because a large number ofthe disorders that the present invention treats occur in the leftventricle and in connection with the, mitral valve. Furthermore, thedevices disclosed herein for improving valve function can be“stand-alone” devices, that is, they do not necessarily have to be usedin conjunction with devices for changing the shape of a heart chamber orotherwise reducing heart wall stress. It also is contemplated that adevice for improving valve function may be placed relative to the heartwithout altering the shape of the chamber, and only altering the shapeof the valve itself.

[0040] Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.

[0041] A currently preferred orientation of transventricular splints forlessening myocardial muscular stresses is shown in FIG. 1, which showsthe short-axis left ventricular cross-section from an anteriorperspective. Examples of particular transventricular splints that areespecially suitable for this application include those shown anddescribed in copending U.S. patent application Ser. No. 09/532,049 toVidlund et al., filed Mar. 21, 2000, entitled “A Splint Assembly forImproving Cardiac Function in Hearts, and Method for Implanting theSplint Assembly,” and comunonly assigned to the assignee of the presentinvention. The complete discosure of that application is incorporated byreference herein. That application will be referred to as “the '049application” in the remainder of this disclosure.

[0042] In the preferred orienation shown in FIG. 1, three splints areplaced in a coplanar fashion, along the long axis of the ventricle,bisecting the left ventricle LV of the heart 10. FIG. 1 is across-section (short axis) view looking from the superior side of theheart. The superior-most splint 14 is placed at approximately the levelof the heads of the papillary muscles PM and below the level of leafletcoaptation, and the additional two splints (not shown in FIG. 1) areplaced inferiorly toward the apex. The preferred orientation shown inFIG. 1 both bisects the left ventricle LV and avoids key structures suchas coronary vessels and the like. The splints according to thisorientation also extend through the septum S near its edge and enter asmall portion of the right ventricle RV.

[0043] Each splint includes a tension member 16 and an anchor assembly18 at each end of the tension member 16. Presently preferred embodimentsof tension members 16, anchor assemblies 18, and their connection to oneanother are disclosed in the '049 application incorporated by referenceabove. As shown in FIG. 1, tension member 16 extends through the theheart wall HW, across the left ventricle LV, and through the septum Sand a portion of the right ventricle RV. Anchor assemblies 18 are placedadjacent the external surface of the heart wall HW.

[0044] As mentioned above, human implantations of splints, including inan orientation shown in FIG. 1, may exacerbate any pre-existing mitralvalve incompetency, including mitral valve regurgitation (MVR), or atthe least, may not improve any pre-existing MVR. FIG. 2a shows anorientation of splints 14 according to an embodiment of the presentinvention which may assist in both offloading myocardial wall stress andin aiding the apposition of valve leaflets. According to thisorientation, each tension member 16 of splint 14 extends through theheart wall HW at a position approximately midway between the anterolateral papillary muscle PM and the posterio medial papillary muscle PM,extends transverse the left ventricle LV, and extends through the septumS at approximately its midpoint. A first anchor assembly 18 is placedexternal the heart 10 adjacent the heart wall HW and a second anchorassembly is placed inside the right ventricle RV adjacent septum S. FIG.2a shows the superior-most splint 14 of preferably three splints, withthe other two splints placed inferiorly towards the apex. More or lessthan three splints may be used. The splints in this orientation aregenerally parallel to one another and substantially perpendicular to thelong axis of the left ventricle.

[0045] The orientation of splints 14 shown in FIG. 2a helps to “pull”both of the papillary muscles PM toward the center of the left ventricleLV and reposition those muscles closer to their normal physiologicalposition relative to the mitral valve annulus during the completecardiac cycle. During the course of heart failure dilation, thepapillary muscles PM are moved laterally away from their normalposition, which causes the chordae connected to both valve leaflets tobecome excessively taut. This in turn inhibits the leaflets from fullyclosing against each other. By bringing the papillary muscles PM closerto the center of the ventricle LV, the chordae are slackened enough toallow the leaflets to appose, thereby improving on mitral valvefunction. Additionally, although the splints 14 in this approach arepreferably positioned at and below the level of the tops of thepapillary muscles PM, the shape change deformation at the superior-mostsplint 14 would extend in a region further superior, and potentiallyinclude the annulus itself. To the extent that the annulus in the regionof the posterior leaflet is deformed, this would further benefit thevalve function by reducing the cross-sectional area of the annulus andpositioning the posterior leaflet and its attachment zone closer to theanterior annulus. This, in turn, will cause the leaflets to more fullyappose, minimizing MVR.

[0046] Various methods may be employed to implant the splints 14 in theorientaion shown in FIG. 2a. One particularly advantageous method is anendovascular delivery technique shown and described in co-pending U.S.patent application Ser. No. ______, to Robert M. Vidlund et al.,entitled “Endovascular Splinting Devices and Methods,” filed on the sameday as this application and commonly assigned to the assignee of thisapplication, the entire i disclosure of which is incorporated byreference herein. Splints 14 also may be positioned in the orientationshown in FIG. 2a by other surgical techniques, such as those describedin the '049 application incorporated by reference above. For example, togain access to the ventricular septum S, a small incision can be placedwithin the right ventricular wall to allow for positioning tensionmember 16 and the anchor assembly 18 within the right ventricle RV. Themethods of implantation shown and described in the applications referredto above may be used in connection with any of the embodiments shown anddescribed herein.

[0047]FIG. 2b shows another orientation of splints 14 according to anembodiment of the present invention which may assist in the offloadingof myocardial wall stress and in the apposition of valve leaflets.According to this orientation, at least one splint 14 is angled withrespect to the long axis of the left ventricle LV, in contrast toorienting the at least one splint 14 perpendicular to the axis of theleft ventricle LV. In the embodiment shown in FIG. 2b, the lower twosplints 14 are angled relative to the ventricular axis and relative tothe superior-most splint 14, which is approximately perpendicular to theventricular axis. In this example, all three splints 14 are coplanar, asis preferred for optimizing the ventricular shape change. While FIG. 2billustrates the ventricular splints having an anchor pad disposed on theseptum, it is contemplated that the benefits of angling one or moresplints relative to the long axis of the ventricle could be achieved atother cross-sectional orientations including, for example, theorientation shown in FIG. 1, in which an anchor pad is located on anexterior wall of the heart as opposed to the septum wall.

[0048] Because the lower two splints 14 are positioned at an angle, theytend to “lift” one or both papillary muscles PM as they impart shapechange to the left ventricle LV. By lifting the papillary muscle(s) PM,some slack may be provided to the chordae connected to the valveleaflets to permit improved apposition of the leaflets of mitral valveMV. It is contemplated that more or less splints than the lower twosplints may be angled (other than perpendicularly) relative to theventricular axis to achieve the benefits to MVR, and that each splintmay have a different angle relative to that axis. For example, all threesplints could be angled, or only one splint could be angled. The numberof splints to be angled, and the degree of such angles, would be chosento optimize the improvement in MVR and would depend on factors such asthe particular anatomy of a heart. The splint positioning can beiteratively changed and the impact on MVR, and mitral valve function ingeneral, can be monitored using appropriate “real-time” imagingtechniques and equipment, such as, for example, ultrasound and othersuitable mechanisms. The ventricular splints 14 shown in FIG. 2b may beoriented in any suitable cross sectional position, including thepositions shown in FIG. 1 or 2 a. The benefits to MVR of angularlypositioning one or more of the ventricular splints 14 relative to theventricular axis, as shown in FIG. 2b, may be achieved independent ofthe particular cross sectional position of the splints 14.

[0049] According to an embodiment of the present invention, a method ofimproving mitral valve function, while maintaining the positions andorientations of the ventricular splints shown in FIG. 1, includes theuse of an additional splint. This additional splint, referred to hereinas a mitral valve splint or MV splint, preferably has the sameconstruction as the other splints and may be implanted using the similardelivery techniques. The primary function of the MV splint is to imparta shape change to the mitral valve annulus, adjacent the leftventricular wall, as well as reposition the papillary muscles PM.

[0050]FIGS. 3a and 3 b show an MV splint according to an embodiment ofthe present invention. FIGS. 3a and 3 b show the three ventricularsplints 14 in the positions and orientations shown and described inconnection with FIG. 1 (the dashed lines in FIGS. 3a, 3 b) and show anexemplary orientation of an MV splint 20. It should be noted that inFIGS. 3a and 3 b the shape change to the left ventricle caused by thetransventricular splints 14 is not illustrated. MV splint 20 ispositioned superior to the papillary muscles PM and oriented primarilyacross the mitral valve MV and on or below the mitral valve annuluswhile avoiding key vascular structures. In this orientation, MV splint20 is “out of plane” with the other ventricular splints 14, as theoverall function of MV splint 20 is to improve and optimize the mitralvalve function. In the example shown in FIGS. 3a and 3 b, the MV splintextends through the heart wall between the papillary muscles of the leftventricle LV, and extends transverse the left ventricle LV, through theseptum S, through the right ventricle RV, and once again through theheart wall.

[0051] The MV splint 20 improves mitral valve function through acombination of effects. First, the shape of the annulus is directlyaltered, preferably during the entire cardiac cycle, thereby reducingthe annular cross sectional area and bringing the posterior leaflet incloser apposition to the anterior leaflet. Second, the position androtational configuration of the papillary muscles PM and surroundingareas of the left ventricle LV are further altered by the tightening ofthe MV splint 20. This places the chordae in a more favorable state oftension, allowing the leaflets to more fully appose each other. Third,since the annulus of the valve is muscular and actively contracts duringsystole, changing the shape of the annulus will also reduce the radiusof curvature of at least portions of the annulus, just as the shapechange induced by the ventricular splints reduces the radius of at leastsignificant portions of the ventricle. This shape change and radiusreduction of the annulus causes off-loading of some of the wall stresson the annulus. This, in turn, assists the annulus's ability to contractto a smaller size, thereby facilitating full closure of the mitral valveMV during systole.

[0052] The position of the MV splint 20 shown in FIGS. 3a and 3 b isexemplary. The ventricular splints 14 preferably are positioned prior topositioning MV splint 20, through the use of, for example, bothangiographic and ultrasonic visualization tools. This positioningtechnique, described in the '049 application incorporated above,achieves optimal positioning of splints 14 to bisect the left ventricleLV and avoid key anatomic structures. After positioning the ventricularsplints 14, a device such as the probe/marking device shown anddescribed in the '049 application may be used to repeatedly probe anddeform possible areas near the mitral valve to find the optimal positionfor the MV splint 20., By utilizing, for example, standard “real-time”ultrasonic imaging techniques, the direct impact of the probing on MVRcan be assessed, and pre-existing MVR or MVR exacerbated by placement ofthe ventricular splints 14 can be corrected. Once the optimal positionfor an MV splint 20 is determined and marked, the MV splint 20 isimplanted and positioned by any of the delivery techniques referred toabove, including the endovascular delivery technique or the more directsurgical approaches. The use of the MV splint 20 allows for the optimalplacement of the ventricular splints 14, which reduce heart wall stress,independent from the optimal subsequent positioning of the MV splint 20,which improves mitral valve function. During implantation, the splintcan be adjusted (either in position or in tightness or both) to optimizeimprovement to valve function, as determined by observation of the valveusing real-time imaging techniques.

[0053] It is anticipated that the optimal position of the MV splint 20could be at virtually any orientation relative to the valve leaflets,depending on the heart failure and mitral valve regurgitation associatedwith the particular heart at issue. For example, in some hearts, theposition shown and described in connection with FIGS. 3a and 3 b mayyield the most improvement of MVR, whereas in other hearts, alternativepositions such as shown in FIG. 3c may yield the most improved results.Note that in FIG. 3c, the transventricular splint is shown positionedbetween the papillary muscles, which may be another preferredorientation for certain hearts. Alternative “A” places MV splint tocause shape change between the papillary muscles Alternative “B” for MVsplint positioning would be in a line more parallel to the valve leafletedges, as shown in FIG. 3d. Other placements of the MV splint, as wellas the position of the transventricular splints, relative to the heartalso are contemplated and could be selected based on the condition ofthe heart and the mitral valve.

[0054] According to another embodiment of the present invention, analternative anchor assembly for the ventricular splints 14 may beprovided to aid in mitral valve function. In the embodiment shown inFIG. 4a, the superior-most splint 14 includes an anchor assembly 28configured for connection to the “free wall” end of that splint 14,i.e., at the exterior wall of the left ventricle. Anchor assembly 28includes a lower portion in the form of, for example, a lower padportion 30 which contacts the external surface of the left ventriclewall somewhat below the level of the tension member 16. In a preferredembodiment, the lower pad portion 30 resembles the shape, size, andconstruction of the anchor pads described in the '049 applicationincorporated above. Anchor assembly 28 further includes an upper portionin the form of, for example, an upper pad portion 34 which contacts asuperior region of the left ventricle wall near the mitral valveannulus. Tension member 16 connects to a spanning structure 32 that, inone embodiment, is preferably integrally fabricated with the lower andupper pad portions 30 and 34, and connects portions 30 and 34. Suitablematerials for anchor assembly may include, but are not limited to, thosedescribed in the '049 application. At least the lower and upper padportions 30 and 34 preferably include a covering or a coating of amaterial, such as, for example, a woven polyester fabric, to encouragetissue in-growth. The spanning structure 32 also may be made of, orinclude a covering or coating made of, a material to encourage tissuein-growth

[0055] In the exemplary, preferred embodiment shown in FIG. 4a, thelower pad portion 30 has a circular shape and the upper pad portion 34has an oblong shape. The oblong shape of the upper pad portion 34 hasthe advantage of inducing relatively extensive shape change along theperiphery of the valve annulus, preferably during the entire cardiaccycle. Therefore, in an embodiment, the length and shape of the upperpad portion may extend a significant distance around the valve annulus.For example, the upper pad portion 34 may extend from about 1 cm inlength to about 10 cm in length, depending on the desired shape changeof the valve annulus. The width of the upper pad portion 34, however, ispreferably relatively narrow, so as to concentrate its shape changeimpact to the region near the valve annulus.

[0056] The upper pad portion 34 may be positioned near, but below, thevalve annulus. In other embodiments of the present invention, the upperpad portion may be positioned directly on the exterior surface of theannulus or somewhat above the annulus to contact the left atrium wall.The position of the upper pad portion preferably avoids directcompressive contact with important vascular structure near or on theexterior surface of the heart. Significant coronary vasculature oftenlies on or near the atrio-ventricular groove 36, which corresponds withthe posterior annular region of the mitral valve. For this reason, itmay be desirable to position the upper pad portion onto the left atrialsurface.

[0057] Anchor assembly 28 permits selection of a position that causesvalve annulus shape change relatively independent from the positioningof the ventricular splints that cause ventricular shape change. Theincorporation of an anchor assembly 28 is most suitable for instanceswhere the desired shape change for the mitral valve is relativelyco-planar with the main ventricular shape change splints. In addition,anchor assembly 28 provides for annulus shape change without the needfor an additional MV splint, such as that shown in FIGS. 3a and 3 b.

[0058] An alternative embodiment of a splint with a mitral valve anchorassembly according to the invention is illustrated in FIG. 4b. In theembodiment of anchor assembly 28, shown in FIG. 4a, the tension member16 was connected to the spanning structure 32 approximately in themiddle of the spanning structure 3, yielding a relatively stablestructure that remains substantially parallel to the exterior surface ofthe heart. However, the embodiment of the anchor assembly 28′ shown inFIG. 4b places the ventricular shape change caused by the lower padportion 30′ below the end of the tension member 16′. The anchor assembly28′ illustrated in FIG. 4b is similar to the anchor assembly 28 of FIG.4a, except that the tension member 16′ is anchored within the lower padportion 30′. In order to provide mechanical balance to the anchorassembly, and to give leverage to the upper pad portion 34′ such that itcan properly alter the region of the valve annulus, a second spanningstructure 33 is provided to mechanically connect the anchor assembly 28′to an anchor pad 14 of the splint disposed below the superior-mostsplint. This second spanning structure 33 also may be integrally formedwith the anchor assembly 28′ and, in turn, with the anchor pad 14.Alternatively, the second spanning structure 33 can be a separatecomponent connecting anchor assembly 28′ and anchor pad 14′ once theyare positioned with respect to the heart. This could be done, forexample, by mechanical fastening, such as with screws or the like.

[0059] A further alternative anchor assembly 28″ is shown in FIG. 4c.This anchor assembly 28″ is similar to the anchor assembly 28 shown inFIG. 4a, except that anchor assembly 28″ also includes one or moreadditional papillary pad portions 35 connected to lower pad portion 30″at a location substantially opposite to spanning structure 32″ Thepapillary pad portion or portions 35 serve to provide one or moreadditional sites of deformation of the ventricular wall, preferably tofurther reposition one or both papillary muscles to aid in appoistion ofthe valve leaflets. The papillary pad portions 35 may be formedintegrally with the anchor assembly 28″ or may be separate and connectedthereto via suitable connection mechanisms.

[0060] In certain cases, the optimal orientation of shape change forimproving the mitral valve function may be significantly offset from theposition and orientation of transventricular splints 14. It is thereforedesirable to have an approach to cause mitral valve shape change atpositions away from the transventricular splints 14, and even moredesirably, without the addition of another splint structure traversingthe ventricle.

[0061]FIG. 5a shows such an approach according to an embodiment of thepresent invention. FIG. 5a shows an accessory anchor pad structure 40attached to a connection member, shown as a runner 42. Runner 42connects at its ends to both anchor pads 18 of preferably thesuperior-most splint assembly 14. As an alternative, runner 42 mayconnect to one anchor pad 18 and extend between that anchor pad 18 andstructure 40. The accessory pad structure 40 is positioned at thelocation on the heart wall that yields the greatest improvement in MVR,as determined with repeated probing and deforming at the exterior of theheart proximate the mitral valve annulus, as described above inconnection with positioning the MV splint 20 in FIGS. 3a and 3 b.

[0062] Since runner 42 preferably connects to the two anchor pads 18 ofthe upper-most splint assembly 14, runner 42 generally runs atapproximately the same level on the heart wall as those anchor pads 18.In one embodiment, accessory anchor pad structure 40 may be of the sameshape and material as the anchor pads 18. While this embodiment mayresult in significantly improved MVR in some instances, in anotherembodiment, accessory pad 40 may take a form, including shape andmaterial, similar to the anchor assemblies 28, 28′, 28″ shown in FIGS.4a-4 c. This latter configuration permits positioning accessory pad 40at a position higher than the level of the anchor pads 18 of thesuperior-most transventricular splint, resulting in even greater shapechange to the mitral valve annulus. Also according to this latterconfiguration, the preferred construction of accessory pad 40 wouldinclude, in addition to characteristics of anchor assembly 28, 28′, 28″,shown in FIGS. 4a-4 c, a connecting mechanism 41 which would allow foradjustable positioning and securing of the accessory pad 41 to runner42. For example, a locking screw 43 may be used to secure runner 42 topad 41. Other mechanisms suitable for securing the pad 41 to the runner42 and permitting adjustment of the pad position along the runner arewithin the scope of the present invention. Runner 42 preferably includesa wire-like, or braid-like, structure which secures to each of thesplint anchor pads 18 also through any suitable means, such as, forexample, a locking screw mechanism 44, a pinning connection for abraid-like runner, or the like.

[0063]FIG. 5b shows an alternative embodiment for connecting anaccessory anchor pad assembly 50 to a runner 52 and for connectingrunner 52 to anchor pads 18. Each end of runner 52 connects to aconnection mechanism in the form of a cap 54. Each cap 54 locks in placeover a pad 18. At least one of the caps 54 includes an adjustablelocking mechanism for adjusting the length of the runner 52 between thecaps 54, and also thereby adjusting the position of the accessory pad 50on the heart wall, and locking the runner 52 to cap 54.

[0064] In one embodiment, runner 52 is a braid formed of a high strengthpolymer, such as that used in the tension members described in the '049application incorporated above. A suitable connection mechanism includesthe use of one or more pins 56 placed through the braided runner 52 andconnected to cap 54 through a flange 58, for example, situated on thecap 54. This pinning connection mechanism may be similar to theconnection used for the braided tension members and anchor pads shownand described in the '049 application. The same connection mechanism maybe used to connect accessory pad 50 to braided runner 52. In analternative embodiment according to the present invention, the braidedrunner 52 may more directly connect to anchor pads 18, without the useof caps 54, by, for example, a pinning securement mechanism incorporatedinto the superior splint pads themselves. In another contemplatedembodiment, the external anchor pad assembly 50, including the runner 52and anchor pads 18, can be used without the transventricular splint toimprove valve function by causing a shape change to the valve annuluswithout an overall shape change to the left ventricle.

[0065] As mentioned above, a mechanism that may exacerbate MVR is therelative rotation of the papillary muscles PM and the adjacent leftventricular wall as the transventricular splints 14 are tightened intoposition. This relative rotation results in slack in some chordae andtightening in other chordae, which may “pull” one valve leaflet (orportion of the leaflet) while “loosening” the other valve leaflet (orportion of the leaflet).

[0066]FIG. 6 shows an embodiment of a device according to the presentinvention that would alleviate this rotation phenomenon. FIG. 6 shows anaccessory splint 70 connected to the superior-most ventricular splint 14by a connecting bar 60. Accessory splint 70 and connecting bar 60preferably are placed at approximately the same level along theventricular wall as splint 14. Splint 14 preferably is positioned nearto, and in this case medial to, the anterior papillary muscle PM.Accessory splint 70 then is positioned through the septum S, across theleft ventricle LV, and through the ventricular free wall between the,papillary muscles PM, similar to MV splint 20 described in connectionwith FIGS. 3a and 3 b but at about the same level as the superior splint14.

[0067] Connecting bar 60 attaches to the ends of tension members 16 and72 at their left ventricular “free wall” ends. Both tension members 16and 72 are tensioned, pressing connecting bar 60 into the left ventricleand effecting shape change to the ventricle and the mitral valveannulus. Connecting bar 60 prevents rotation of the left ventricle LV inthe region of the anterior papillary muscle PM and causes uniformtensioning of the chordae associated with that papillary muscle PM andany associated ventricular wall. This is believed to lessen anydegradation in MVR, and potentially improve the MVR, because thepapillary muscles PM are brought to a more desired position, with lessrotation, particularly as to the anterior papillary muscle.

[0068] The embodiments of the present invention described in connectionwith FIGS. 2a to 6 have been described in connection with the use oftransventricular splints used to geometrically reshape a chamber of theheart and thereby lessen heart wall stresses and reduce dilatation.While the devices and related methods described herein would furtherbenefit the ventricular splinting procedure and its effects, the devicesand related methods of the present invention may be used independent ofthe ventricular splinting to improve dilatation and instead be used forrepairing heart valves, and particularly mitral valves, without the useof adjunctive ventricular splints. For example, a mitral valve splintsuch as that shown in FIGS. 3a, 3 b, and 3 c could be utilized withoutadditional ventricular shape change splints.

[0069] Moreover, while many of the embodiments of the present inventionhave been described in connection with modifications to transventricularsplinting structures, the same or similar modifications may be made toexternal-type devices for causing ventricular shape change. Examples ofsuch external devices are shown in co-pending U.S. patent applicationSer. No. 09/157,486 (“the '486 application”) filed Sep. 21, 1998 andentitled “External Stress Reduction Device and Method,” the completedisclosure of which is incorporated by reference herein. Modifying thoseexternal devices in a similar manner as with the transventricularsplints will achieve beneficial impacts to the mitral valve function.For example, the accessory anchor pad shown in FIGS. 5a and 5 b could beutilized in conjunction with an external stress reduction device, asshown, for example, in FIG. 7. In FIG. 7, an external splint 199 havinga generally U-shaped configuration and including an anterior arm 199 aand a posterior arm 199 b, is positioned with respect to the leftventricle to create a substantially bi-lobed shape. In a preferredembodiment, the U-shaped external splint is made from a material thatpermits the splint to elastically deform under operational loads andalso from a material that is biocompatible. Examples of preferredmaterials include e-PTFE, or a polyester such as Dacron, for example.Such a splint, as well as other suitable external splints, is describedin more detail in the '486 application incorporated above. As shown inFIG. 7, a runner 298, similar to the runner described with reference toFIGS. 5a and 5 b, attaches at its ends to the arms 199 a, 199 b. Anaccessory anchor pad 299, also similar to the accessory anchor assemblydiscussed with reference to FIGS. 5a and 5 b, attaches to the connectingrunner 298. The runner 298 and accesory anchor pad 299 are positionedwith respect to the heart so as to alter the shape of the mitral valveannuls to assist in coaptation of the valve leaflets. Alternatively, therunner and accessory anchor pad could be positioned so as to provide arepositioning of the papillary muscles, also to assist in coaptation ofthe valve leaflets.

[0070] It will be apparent to those skilled in the art that variousmodifications and variations can be made in the devices and relatedmethods for improving mitral valve function of the present invention andin construction of such devices without departing from the scope orspirit of the invention. As an example, a combination of devicesdepicted above may be used for achieving improved mitral valve function.In one such combination, an accessory splint such as MV splint 20 shownin FIGS. 3a and 3 b may include an anchor assembly 28 as shown in FIG. 4and/or an accesory anchor pad structure 40 or 50 shown in FIGS. 5a and 5b. Other embodiments of the invention will be apparent to those skilledin the art from consideration of the specification and practice of theinvention disclosed herein. The specification and examples are exemplaryonly, with a true scope and spirit of the invention being indicated bythe following claims.

What is claimed is:
 1. A method for improving the function of a valve ofa heart, the method comprising the steps of: placing an elongate membertransverse a heart chamber so that a first end of the elongate memberextends through a wall of the heart between two papillary muscles, and asecond end of the elongate member extends through a septum of the heart;placing a first anchoring member external the heart; and placing asecond anchoring member inside the heart adjacent the septum, the firstand second anchoring members being attached to the first and second endsof the elongate member respectively to fix the elongate member in aposition across the heart chamber.
 2. The method of claim 1, wherein theheart chamber is the left ventricle and the valve is the mitral valve.3. The method of claim 2, wherein the first end of the elongate memberextends through a wall of the heart approximately midway between theantero lateral papillary muscle and the posterio medial papillarymuscle.
 4. The method of claim 3, wherein the elongate member is placedproximate the mitral valve.
 5. The method of claim 1, wherein theelongate member is fixed in the position so as to change a shape of theheart chamber.
 6. The method of claim 1, wherein the elongate member isfixed in the position so as to reposition the papillary muscles.
 7. Amethod for improving the function of a valve of a heart, the methodcomprising the steps of: placing a first elongate member transverse aheart chamber so that each end of the first elongate member extendsthrough a wall of the heart; placing first and second anchoring membersexternal the chamber, the first and second anchoring members beingattached to the ends of the first elongate member to fix the firstelongate member in a first position across the chamber; placing a secondelongate member transverse the heart chamber so that each end of thesecond elongate member extends through a wall of the heart; placingthird and fourth anchoring members external the chamber, the third andfourth anchoring members being attached to the ends of the secondelongate member to fix the second elongate member in a second positionacross the chamber, wherein the first and second positions aresubstantially coplanar and have differing angles relative to an axis ofthe chamber.
 8. The method of claim 7, wherein the heart chamber is theleft ventricle and the valve is the mitral valve.
 9. The method of claim7, wherein the first and second elongate members are fixed in the firstand second positions so as to change a shape of the heart chamber. 10.The method of claim 7, wherein the first and second elongate members arefixed in the first and second positions so as to reposition papillarymuscles within the chamber.
 11. A method for improving the function of avalve of a heart, the method comprising the steps of: placing anelongate member transverse a heart chamber so that each end of theelongate member extends through a wall of the heart; and placing firstand second anchoring members external the chamber, the first and secondanchoring members being attached to the ends of the elongate member tofix the elongate member in a position across the chamber, wherein theposition is superior to the papillary muscles and proximate andsubstantially across the valve.
 12. The method of claim 11, wherein theheart chamber is the left ventricle and the valve is the mitral valve.13. The method of claim 11, wherein the position of the elongate memberalters a shape of an annulus of the valve.
 14. The method of claim 11,wherein the position of the elongate member repositions the papillarymuscles within the chamber.
 15. A splint for improving the function of avalve of a heart, the splint comprising: an elongate member configuredto be positioned transverse a heart chamber so that each end of theelongate member extends through a wall of the heart; and first andsecond anchoring members configured to be positioned external thechamber and attached to the ends of the elongate member to fix theelongate member in a position across the chamber, wherein the firstanchoring member includes a first portion configured to contact a firstregion of the heart proximate the valve to change a shape of the valve.16. The splint of claim 15, wherein the heart chamber is the leftventricle and the valve is the mitral valve.
 17. The splint of claim 16,wherein the first region of the heart is a superior portion of the leftventricle proximate an annulus of the mitral valve.
 18. The splint ofclaim 16, wherein the first region of the heart is a portion of the leftatrium proximate an annulus of the mitral valve.
 19. The splint of claim15, wherein the first portion has an oblong shape.
 20. The splint ofclaim 15, wherein the first anchoring member further includes a secondportion configured to contact a second region of the heart below thefirst region.
 21. The splint of claim 20, wherein the second portionincludes a first structure connected to the elongate member and a secondstructure connected to the first portion by the first structure.
 22. Asplint for improving the function of a valve of a heart, the splintcomprising: an elongate member configured to be positioned transverse aheart chamber so that each end of the elongate member extends through awall of the heart; first and second anchoring members configured to bepositioned external the chamber and attached to the ends of the elongatemember to fix the elongate member in a position across the chamber; anda third anchoring member connected to at least one of the first andsecond anchoring members by a connection member, the third anchoringmember configured to contact a region of the heart proximate the valveto change a shape of the valve.
 23. The splint of claim 22, wherein thethird anchoring member connects to the first and second anchoringmembers by the connection member.
 24. The splint of claim 22, whereinthe third anchoring member includes a connection mechanism forconnecting the third anchoring member to the connection member.
 25. Thesplint of claim 24, wherein the connection mechanism includes a lockingscrew.
 26. The splint of claim 24, wherein the connection mechanismincludes a pin.
 27. The splint of claim 22, further comprising aconnection mechanism for connecting the connection member to the atleast one of the first and second anchoring members.
 28. The splint ofclaim 27, wherein the connection mechanism includes a locking screw. 29.The splint of claim 27, wherein the connection mechanism includes a pin.30. The splint of claim 27, wherein the connection mechanism includes acap configured to fit over the at least one of the first and secondanchoring members.
 31. The splint of claim 23, further comprising anadjustment mechanism for adjusting a length of the connection memberbetween the first and second anchoring members.
 32. A device forimproving the function of a valve of a heart, the device comprising: afirst splint having a first elongate member configured to be positionedtransverse a heart chamber so that each end of the elongate memberextends through a wall of the heart, and a first anchoring memberconfigured to be positioned external the chamber and attached to a firstend of the first elongate member; a second splint having a secondelongate member configured to be positioned transverse a heart chamberso that each end of the second elongate member extends through a wall ofthe heart, and a second anchoring member configured to be positionedexternal the chamber and attached to a first end of the second elongatemember; and a connecting mechanism configured to be connected to thesecond ends of each of the first and second elongate members externalthe chamber and press the wall of the heart chamber to change the shapeof an annulus of the valve.
 33. The device of claim 32, wherein theconnection mechanism is a bar.
 34. The device of claim 32, wherein theheart chamber is the left ventricle and the valve is the mitral valve.35. The device of claim 32, wherein the device is configured so that theconnecting bar presses the wall of the heart chamber to change the shapeof chamber.
 36. A method for improving the function of a valve of aheart, the method comprising the steps of: placing an elongate membertransverse a heart chamber so that each end of the elongate memberextends through a wall of the heart; and placing first and secondanchoring members external the chamber, the first and second anchoringmembers being attached to first and second ends of the elongate memberto fix the elongate member in a position across the chamber so as toreposition papillary muscles within the chamber.
 37. The method of claim36, wherein the first end of the elongate member extends through a wallof the left ventricle between papillary muscles.
 38. The method of claim37, wherein the second end of the elongate member extends through aseptum of the heart.
 39. The method of claim 36, wherein the chamber isthe left ventricle and the valve is the mitral valve.
 40. The method ofclaim 36, wherein the position is superior to the papillary muscles andproximate and substantially across the valve.
 41. The method of claim36, wherein the elongate member is fixed in the position so as to alterthe shape of an annulus of the valve.
 42. A method for improving cardiacfunction, comprising: placing a first member relative to a heart chamberto alter the cross-sectional shape of the chamber; and placing a secondmember relative to a valve of the heart chamber to assist in appositionof leaflets of the valve.
 43. The method of claim 42, wherein each ofthe first and second members includes a portion placed transverse thechamber.
 44. The method of claim 42, wherein each of the first andsecond members includes an elongate member.
 45. The method of claim 44,wherein the placing each of the first and second elongate membersincludes securing the elongate members relative to the heart chamberwith anchors configured to engage each end of the elongate members andconfigured to engage an exterior surface of a wall surrounding the hearschamber.
 46. The method of claim 45, wherein the securing the secondelongate member includes engaging one of the anchors with an exteriorsurface of the heart wall proximate the valve to alter a shape of anannulus of the valve.
 47. The method of claim 42, wherein the heartchamber is a left ventricle.
 48. The method of claim 42, wherein thevalve is a mitral valve.
 49. The method of claim 42, wherein the placingthe second member includes altering the cross-sectional shape of anannulus of the valve.
 50. The method of claim 42, wherein the placingthe second member includes reducing a radius of an annulus of the valve.51. The method of claim 42, wherein the placing the second memberincludes placing the second member so as to alter a position of at leastone papillary muscle of the heart chamber.
 52. The method of claim 51,wherein the placing the second member includes securing the secondmember with respect to the heart chamber with an anchor configured toengage an exterior surface of a wall surrounding the heart chambersubstantially at a location of the at least one papillary muscle. 53.The method of claim 42, wherein the placing the first member includesplacing an elongate member transverse the heart chamber and through awall surrounding the heart chamber at substantially opposite locationson the heart wall.
 54. A method of improving the function of a valve ofa heart, the method comprising: applying a force to an exterior surfaceof a wall surrounding a chamber of the heart substantially at a locationof the valve to alter a shape of the valve.
 55. The method of claim 54,wherein applying the force alters the shape of an annulus of the valve.56. The method of claim 54, wherein altering the shape of the valveincludes appositioning leaflets of the valve.
 57. The method of claim54, wherein altering the shape of the valve includes reducing a radiusof an annulus of the valve.
 58. The method of claim 54, wherein theforce is applied by a device having an elongate member placed transversethe chamber and a first anchor assembly connected at a first end of themember external the chamber and a second anchor assembly connected at asecond end of the member external the chamber.
 59. A method forimproving the function of a valve of a heart, comprising: placing adevice relative to the heart to alter a shape of the valve; andadjusting the device relative to the heart based on data obtained duringthe adjusting from real-time monitoring of valve function.
 60. Themethod of claim 59, wherein the device is a splint.
 61. The method ofclaim 59, wherein the device is a splint and adjusting the splintincludes changing a distance between at least two portions of the splintthat contact respective portions of the heart.
 62. The method of claim59, wherein the real-time monitoring includes imaging the valve.
 63. Themethod of claim 62, wherein the imaging of the valve includes ultrasoundimaging.